David B. asks, "Any comment on Cleveland BioLabs' (CBLI - Get Report) anti-radiation drug?" I fail to see how Cleveland BioLabs will fare any better than Hollis-Eden Pharmaceuticals. Does anyone remember Hollis-Eden? In the aftermath of 9/11 when people were obsessed with the threat of terrorists detonating nuclear dirty bombs, the small San Diego drug company was thrust into the spotlight for its work developing an anti- radiation treatment. Hollis-Eden executives lobbied Washington D.C. law makers hard and secured Pentagon and Defense Department research contracts. Heck, Hollis-Eden even managed to land a high-profile story about its radiation drug on 60 Minutes. All this work and promotion was supposed to lead to a huge bioterrorism stockpiling order for Hollis-Eden's anti-radiation drug. Except it didn't. In 2007, the U.S. government canceled its contracts with Hollis-Eden, sending the stock plummeting and essentially destroying the company. Hollis-Eden never recovered and eventually changed its name to Harbor BioSciences ( HRBR), trading on the bulletin boards. To me, Cleveland BioLabs is an exact replay of Hollis-Eden. The drugs might be different, and worries of nuclear-armed terrorists have been replaced with fears about a broken Japanese nuclear power plant, but the overall script is the same. Cleveland BioLabs has been and may continue to be a great trading stock, but I don't see this endgame working out any better than it did for Hollis-Eden. A friend who runs the Web site Biotech Investment Paradigm conducted an interview recently with Cleveland BioLab's CEO, if you're interested in more.
Readers sent in a lot of suggested additions to my early ASCO 2011 cancer drug target list. Thank you all for contributing. It's going to be a tad quiet at ASCO this year because a lot of small and mid-cap biotech companies are in the middle of, or just starting, pivotal cancer drug clinical trials and therefore won't have meaningful new data to report at the meeting.
Robert P. emails, "I e-mailed you last fall about Vanda Pharmaceuticals (VNDA - Get Report) and you did respond. So here we are five months later and nothing has changed. Vanda doesn't take calls nor answer them. Why does a company have an investor relations department that doesn't respond to shareholders? Sounds like a cushy job. I'm beginning to think that Novartis has written them off. And the shelf offering. Any idea on the purpose? In any case, in my 45 years of investing, this company has the worst record of treating shareholders with any respect. The only good thing is I'm still up on my investment." I'm happy to let you vent, Bob. Unfortunately, no one at Vanda is listening.
Scott writes, "What are the chances of Amylin Pharmaceuticals' (AMLN) approval of Bydureon in the next few months with the European regulatory authority? I think they should be giving a ruling shortly. What effect do you think it will have on the stock price? I was a little surprised when InterMune (ITMN) went up 150-200% in a month. Do you think Amylin could potentially do that since some think it could be a real game changer." With all the attention and controversy surrounding the FDA's rejection of Bydureon last fall, I forgot that Amylin's partner Eli Lilly ( LLY) filed for Bydureon's approval in Europe. A decision could come in the first half of the year. I don't have a complete sense of investor expectations for Bydureon's chance of a European approval, but I did talk Thursday with a buy-side source who has been short Amylin since before the FDA rejecton. He gives 50-50 odds for a European approval of Bydureon, and for that reason and others (the stock is relatively close to his price target), he's been covering. A biotech analyst who asked not to be quoted by name told me that he thinks Bydureon has better than a 50% shot getting approved in Europe, mainly because he doesn't believe European regulators are as concerned about the drug's safety issues that bogged down the drug at the FDA. If Bydureon is approved in Europe, Amylin shares will rise, but I wouldn't expect a doubling in the stock price like you saw with InterMune when pirfenidone was approved across the pond. Pirfenidone is the only drug available to treat idiopathic pulmonary fibrosis. Bydureon, of course, has lots of competition in diabetes, even if the weekly injection is more convenient than its closest competitor, Novo Nordisk's ( NVO) daily injectable Victoza.
Sarah N. asks, "Anything left with Xoma (XOMA - Get Report) or is the stock dead?" Dead. XOMA '052 flopped in diabetes this week, so now Xoma management is moving to plan B, which is to develop '052 as a cardiovascular therapy based on data showing the drug lowers levels of C-reactive protein. Merely showing some improvement in an inflammatory biomarker isn't enough to get a cardiovascular drug approved, and I have no confidence at all in the ability of Xoma or its partner Servier to do anything right when it comes to '052.
In lieu of hate email this week, you have to check out the blizzard of bizarre comments, insults and conspiracy theories posted by fans of Radient Pharmaceuticals ( RPC) in reaction to my most recent story. Hilarious. --Written by Adam Feuerstein in Boston. >To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: firstname.lastname@example.org.